Solid Tumors
Conditions
Keywords
Patients with non-CNS or CNS tumors, Pediatric patients with Relapsed/Refractory Solid Tumors
Brief summary
The goal of this clinical research study is to find the highest tolerable dose of EZN-2208 that can be given to pediatric patients with Relapsed or Refractory Solid Tumors. The safety of the study drug and its effect on the disease will also be studied.
Detailed description
Pharmacokinetic (PK) testing of EZN-2208, will be performed for patients who volunteer. PK testing measures the amount of a drug in the body at different time points.
Interventions
DRUGEZN-2208
Experimental
Sponsors
Enzon Pharmaceuticals, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 21 Years
Healthy volunteers
No
Inclusion criteria
* Patients with histologic verification of malignancy at original diagnosis or relapse. * Measurable or evaluable disease * Karnofsky score more or equal to 50 for patients \>16 years of age and Lansky score more or equal to 50 for patients \<16 years of age * Patients previously treated with irinotecan will be eligible for this study if they have not had documented progressive disease during treatment with an irinotecan-containing regimen. * Adequate hematologic, hepatic, coagulation, renal, and metabolic function
Exclusion criteria
* Pregnant or breast feeding patients will not be enrolled in this study * Patients who are currently receiving other anticancer agents * Patients who have an uncontrolled infection * Patients requiring cytochrome P450 3A4 enzyme inducing or inhibiting agents
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine the MTD and recommended phase 2 dose of i.v. EZN-2208 administered q3wk. | 2 years | The study will measure incidence, severity and duration of adverse events graded by NCI CTCAE during first cycle of therapy to determine the MTD. A Phase 2 Dose will be recommended by study investigators after considering the frequency and severity of adverse events and the ability to maintain dose schedule |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assess evidence of tumor response activity of EZN-2208 | 2 years | An evaluation of objective Tumor response by radiographic scans will be performed every two cycles following the criteria of RECIST 1.1. |
| Evaluate the safety and tolerability of EZN-2208 | 2 years | The incidence, severity and duration of adverse events graded by NCI CTCAE during all cycles of therapy will be used to assess safety and tolerability. |
| Assess the PK profile of EZN-2208 | 2 years | The pharmacokinetics of EZN-2208 will be established by measuring the concentration of EZN-2208 and SN-38 over time in patient blood samples. |
Countries
United States
Outcome results
None listed